SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study) - NCT00265564-94304 (Clinical Trial 133978)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy133978.aspx
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| City: |
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Palo Alto |
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State:
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CA |
| Zip Code: |
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94304 |
| Conditions: |
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Substance Use Disorders - Posttraumatic Stress Disorder |
| Purpose: |
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This study proposes a prospective program of research that will identify feasible and
inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby
improving substance abuse treatment outcomes.
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| Study summary: |
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Background: This study proposes a prospective program of research that will identify
feasible and inexpensive methods to detect and treat comorbid PTSD among VA SUD patients,
thereby improving substance abuse treatment outcomes.
Objective(s): Our objectives are to test the effectiveness of substituting 2 hours/week of
Seeking Safety-based groups for standard substance use focused groups for male patients
attending outpatient substance use disorder treatment who meet clinical criteria for PTSD.
Primary outcomes measures will assess substance use disorder severity and secondary outcome
measures will assess mental health and substance use related problems plus treatment
satisfaction. We hypothesize that enhanced SUD treatment that incorporates "Seeking Safety"
will improve SUD treatment outcomes for PTSD-SUD patients as compared to outcomes for
PTSD-SUD patients receiving treatment as usual. Additionally, we examine two hypothesized
models via which "Seeking Safety" may effect substance use outcomes. We examine whether 1)
reductions in PTSD symptomatology and 2) improvements in coping strategies used in response
to PTSD symptoms (reductions in using to cope and other avoidance coping strategies)
partially mediate the effect of treatment on substance use outcomes.
Methods: This is a randomized clinical trial of 210 male veterans with PTSD and substance
use disorders attending outpatient substance use disorder treatment at the VA Oakland mental
health center. Patients will be randomized to 3 months of outpatient substance abuse
treatment including either 2 hours/week of "Seeking Safety" or standard addiction focused
group therapy. Data will be collected in patient interviews at treatment entry and at 3, 6
and 12 months after treatment initiation and by medical record review. Substance use, PTSD
symptomatology, mental health, social functioning, legal problems, use of coping techniques,
and treatment satisfaction outcomes will be assessed at treatment entry and 3, 6 and 12
months later using well-validated survey instruments. Primary and secondary treatment
outcomes of patients in "Seeking Safety" versus treatment as usual will be compared by
repeated measures ANCOVA. We will test the mediational hypotheses according to the 4-step
method described by Baron and Kenny (1986).
Status: Project began in January, 2006; Recruitment, treatment and assessment is ongoing |
| Criteria: |
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Inclusion Criteria:
1. veteran status and VA healthcare eligibility,
2. a diagnosis of any alcohol or drug use disorder,
3. having completed an intake for outpatient SUD treatment at the VA Oakland outpatient
mental health clinic, and
4. meeting criteria for a PTSD diagnosis based on a preliminary screen with the PC-PTSD
and subsequent full clinical evaluation using the CAPS
Exclusion Criteria:
1. current participation in any day or inpatient mental health treatment,
2. any contraindications communicated by that patient's primary clinician,
3. acute psychosis, mania, dementia, or suicidal intent |
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| Study is available at: |
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VA Palo Alto Health Care System
Palo Alto, CA 94304
United States
Primary Contact:
Jodie A Trafton, PhD
Email: Jodie.Trafton@va.gov
Phone: 650-493-5000
Secondary Contact:
Jodie A Trafton, PhD
Email: Jodie.Trafton@va.gov
Phone: (650) 493-5000 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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